Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT00671034
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595188', 'term': 'calaspargase pegol'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'C488629', 'term': 'azathiopurine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D013866', 'term': 'Thioguanine'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Data is not and never will be available for Outcome Measure 10, Relationship between PK and presence of antibodies.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'calaspargase pegol 2100', 'otherNumAtRisk': 69, 'otherNumAffected': 64, 'seriousNumAtRisk': 69, 'seriousNumAffected': 54}, {'id': 'EG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'calaspargase pegol 2500', 'otherNumAtRisk': 42, 'otherNumAffected': 40, 'seriousNumAtRisk': 42, 'seriousNumAffected': 34}, {'id': 'EG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'pegaspargase 2500', 'otherNumAtRisk': 54, 'otherNumAffected': 51, 'seriousNumAtRisk': 54, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 33, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 88, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 60, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 56, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Malabsorption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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{'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 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'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 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'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) (Half-life of SC-PEG E. 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Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '97.5'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '87.4', 'upperLimit': '99.9'}, {'value': '94.1', 'groupId': 'OG002', 'lowerLimit': '83.8', 'upperLimit': '98.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of induction (Day 29)', 'description': 'Complete Remission (CR) rate; where CR is defined as M1 marrow (\\< 5% lymphoblasts in the bone marrow)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.35', 'groupId': 'OG000', 'lowerLimit': '60.98', 'upperLimit': '83.72'}, {'value': '80.8', 'groupId': 'OG001', 'lowerLimit': '68.3', 'upperLimit': '93.3'}, {'value': '79.34', 'groupId': 'OG002', 'lowerLimit': '67.56', 'upperLimit': '91.12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 Years', 'description': 'Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asparaginase Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'title': 'Level at least 0.1 IU/mL day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.8'}]}]}, {'title': 'Level at least 0.1 IU/mL day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '100.0'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '98.1', 'upperLimit': '100'}]}]}, {'title': 'Level at least 0.1 IU/mL day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '98.5'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '100'}, {'value': '95.1', 'groupId': 'OG002', 'lowerLimit': '77.9', 'upperLimit': '97.4'}]}]}, {'title': 'Level at least 0.1 IU/mL day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '80.1', 'upperLimit': '96.4'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '99.4'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '43.7'}]}]}, {'title': 'Level at least 0.4 IU/mL day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.8'}]}]}, {'title': 'Level at least 0.4 IU/mL day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '63.3', 'upperLimit': '85.8'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '99.4'}, {'value': '93.0', 'groupId': 'OG002', 'lowerLimit': '80.9', 'upperLimit': '98.5'}]}]}, {'title': 'Level at least 0.4 IU/mL day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '22.3', 'upperLimit': '47.0'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '77.3'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '27.9'}]}]}, {'title': 'Level at least 0.4 IU/mL day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '23.9'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '43.9'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 4, 15, 22 and 29 of Induction', 'description': 'The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected.'}, {'type': 'SECONDARY', 'title': 'Plasma and CSF Concentrations of Asparagine in ug/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'title': 'CSF asparagine concentration (ug/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Plasma asparagine concentration (ug/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.784', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '1.231', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '2.195', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 Days Post-dose (Day 29)', 'description': 'The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '25 Days Post-dose (Day 29)', 'description': 'Number of Patients with Positive Immunogenicity tests', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected.'}, {'type': 'SECONDARY', 'title': 'Toxicities During Post Induction Intensification Therapy (All Grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'classes': [{'title': 'Alergic Reaction - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '23.3', 'groupId': 'OG002'}]}]}, {'title': 'Alergic Reaction - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Alergic Reaction - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'CNS - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'CNS - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'CNS - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperbilirubinemia - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': '30.2', 'groupId': 'OG002'}]}]}, {'title': 'Hyperbilirubinemia - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}]}]}, {'title': 'Hyperbilirubinemia - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000'}, {'value': '42.4', 'groupId': 'OG001'}, {'value': '46.5', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}, {'value': '36.8', 'groupId': 'OG002'}]}]}, {'title': 'Hyperglycemia - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}, {'title': 'Hyperlipidemia - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperlipidemia - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperlipidemia - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': '% patients w/INR increase - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '7.0', 'groupId': 'OG002'}]}]}, {'title': '% pts w/INR increase - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '% patients w/INR increase - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatitis - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '7.0', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatitis -Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatitis - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '2.6', 'groupId': 'OG002'}]}]}, {'title': '% pts w/prolongation of APT time - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '7.0', 'groupId': 'OG002'}]}]}, {'title': '% pts w/prolongation APT time -Delayed Intension I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}, {'value': '18.4', 'groupId': 'OG002'}]}]}, {'title': '%pts w/prolongation APT time-Interim maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis - Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis - Delayed Intensification I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Thrombosis - Interim Maintenance I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT)'}, {'type': 'SECONDARY', 'title': 'Relationship Between PK and Presence of Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'OG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'timeFrame': 'Day 29 of consolidation', 'description': 'Patients with presence of Antibodies.', 'reportingStatus': 'POSTED', 'populationDescription': 'These data will never be collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'FG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.'}, {'id': 'FG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'VHR ALL feature', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'includes Alternative therapy, etc.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Calaspargase Pegol 2100)', 'description': 'calaspargase pegol 2100'}, {'id': 'BG001', 'title': 'Arm II (Calaspargase Pegol 2500)', 'description': 'calaspargase pegol 2500'}, {'id': 'BG002', 'title': 'Arm III (Pegaspargase 2500)', 'description': 'pegaspargase 2500'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '5.58', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '6.09', 'groupId': 'BG001'}, {'value': '10.79', 'spread': '5.54', 'groupId': 'BG002'}, {'value': '11.3', 'spread': '5.72', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-02', 'studyFirstSubmitDate': '2008-05-01', 'resultsFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-04', 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)', 'timeFrame': 'Post Day 29 of Induction and Post Day 22 of Consolidation', 'description': 'Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics (PD)', 'timeFrame': 'Day 29 of consolidation and induction', 'description': 'Plasma Asparaginase Concentration During consolidation and induction.'}, {'measure': 'Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction', 'timeFrame': 'End of induction (Day 29)', 'description': 'Percentage of participants with Negative MRD (MRD\\<0.01%).'}, {'measure': 'Percentage of Participants With Complete Remission at the End of Induction', 'timeFrame': 'End of induction (Day 29)', 'description': 'Complete Remission (CR) rate; where CR is defined as M1 marrow (\\< 5% lymphoblasts in the bone marrow)'}, {'measure': 'Percentage of Participants With Event-free Survival (EFS)', 'timeFrame': '5 Years', 'description': 'Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.'}, {'measure': 'Asparaginase Level', 'timeFrame': 'Days 4, 15, 22 and 29 of Induction', 'description': 'The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar'}, {'measure': 'Plasma and CSF Concentrations of Asparagine in ug/ml', 'timeFrame': '25 Days Post-dose (Day 29)', 'description': 'The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.'}, {'measure': 'Immunogenicity', 'timeFrame': '25 Days Post-dose (Day 29)', 'description': 'Number of Patients with Positive Immunogenicity tests'}, {'measure': 'Toxicities During Post Induction Intensification Therapy (All Grades)', 'timeFrame': 'Up to 5 years', 'description': 'The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.'}, {'measure': 'Relationship Between PK and Presence of Antibodies', 'timeFrame': 'Day 29 of consolidation', 'description': 'Patients with presence of Antibodies.'}]}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Adult B Acute Lymphoblastic Leukemia', 'Childhood B Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '30626253', 'type': 'DERIVED', 'citation': "Schore RJ, Devidas M, Bleyer A, Reaman GH, Winick N, Loh ML, Raetz EA, Carroll WL, Hunger SP, Angiolillo AL. Plasma asparaginase activity and asparagine depletion in acute lymphoblastic leukemia patients treated with pegaspargase on Children's Oncology Group AALL07P4. Leuk Lymphoma. 2019 Jul;60(7):1740-1748. doi: 10.1080/10428194.2018.1542146. Epub 2019 Jan 10."}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the pharmacokinetic comparability of EZN-2285 (calaspargase pegol) compared to Oncaspar (pegaspargase) given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Munster (BFM) therapy.\n\nSECONDARY OBJECTIVES:\n\nI. To describe the pharmacodynamics (PD) of EZN-2285 compared to Oncaspar given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented BFM therapy.\n\nII. To determine end of induction therapy day 29 minimal residual disease (MRD) for patients randomized to the EZN-2285 containing regimen compared to the Oncaspar® containing regimen.\n\nIII. To determine the complete remission (CR) rates for patients receiving EZN-2285 by day 29 of induction compared to Oncaspar.\n\nIV. To assess event-free survival (EFS) associated with the administration of EZN-2285 given during augmented post Induction intensification therapy to patients with high-risk ALL compared to Oncaspar.\n\nV. To determine the proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on days 4, 15, 22 and 29 of induction compared to Oncaspar.\n\nVI. To determine the plasma and cerebrospinal fluid (CSF) concentrations of asparagine after administration of EZN-2285 compared to Oncaspar.\n\nVII. To assess the immunogenicity of EZN-2285 including the detection of binding and neutralizing antibodies compared to Oncaspar.\n\nVIII. To assess the tolerability and toxicities associated with the administration of EZN-2285 given during augmented post induction intensification therapy to patients with high risk ALL compared to Oncaspar.\n\nIX. To explore the relationship between the terminal pharmacokinetics (PK) of EZN-2285 and the presence of antibodies.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to response to induction therapy (slow early responders \\[SER\\] vs rapid early responders \\[RER\\]. Patients are randomized to 1 of 2 treatment arms in 2:1 ratio (arm I: arm II) (patients randomized to arm I receive study drug calaspargase pegol\\*; patients randomized to arm II receive study drug pegaspargase).\n\nINDUCTION THERAPY\\*\\* (ALL PATIENTS): Patients receive cytarabine intrathecally (IT) on day 1; vincristine intravenously (IV) and daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; prednisone orally or IV twice daily (BID) on days 1-28; study drug IV over 1 hour on day 4; and methotrexate IT on days 8, 15\\*, 22\\*, and 29. Patients are assessed for response on day 8 and/or day 15 and day 29. Patients who achieve M1 marrow on day 8 or 15 and negative MRD (i.e., \\< 0.1%) on day 29 are considered RER. Patients who achieve M2 or M3 marrow on day 15 OR MRD \\>= 0.1% but \\< 1% on day 29 are considered SER. Patients with M3 bone marrow are removed from the study. RER and SER proceed to consolidation therapy. Patients with M2 marrow or M1 marrow with \\>= 1% MRD receive extended induction therapy. Patients also receive dexamethasone PO or IV BID on days 1-14 (patients \\< 10 years) or prednisone BID on days 1-28 (patients \\>= 10 years)\n\nNOTE: \\*For patients with CNS3 disease only.\n\nEXTENDED INDUCTION THERAPY\\*\\*: Patients receive vincristine IV on days 1 and 8; prednisone orally (PO) or IV BID on days 1-14; daunorubicin hydrochloride IV over 15 minutes on day 1; and study drug IV over 1 hour on day 4. Patients are assessed for response on day 43. Patients who achieve M1 and MRD \\< 1% are treated as SER (proceed to consolidation therapy). All other patients are removed from study.\n\nCONSOLIDATION THERAPY\\*\\* (ALL PATIENTS): Beginning on day 36 (after completion of induction therapy) or after completion of extended induction therapy, patients (RER and SER) receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; study drug IV over 1 hour on days 15 and 43; and methotrexate IT on days 1, 8, 15\\*, and 22\\*. Patients then proceed to interim maintenance I therapy.\n\nNOTE: \\*Omit doses for patients with CNS3 disease.\n\nINTERIM MAINTENANCE I\\*\\* (ALL PATIENTS): Patients receive vincristine IV and methotrexate\\*\\* IV on days 1, 11, 21, 31, and 41; study drug IV over 1 hour on days 2 and 22; and methotrexate IT on days 1 and 31. Patients then proceed to delayed intensification I therapy.\n\nDELAYED INTENSIFICATION I\\*\\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-21 for patients age 1-9, or on days 1-7 and 15-21 for patients age \\>= 10; doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; study drug IV over 1 hour on days 4 and 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or subcutaneously (SC) on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1, 29, and 36. Patients treated as RER proceed to maintenance therapy. Patients treated as SER (i.e., patients with CNS3 disease at diagnosis, or pre-treated with steroids, or who are RERs with mixed lineage leukemia \\[MLL\\] gene rearrangements) proceed to interim maintenance II followed by delayed intensification II.\n\nINTERIM MAINTENANCE II\\*\\* (SER ONLY): Patients receive vincristine IV, methotrexate IV, study drug IV, and methotrexate IT as in interim maintenance I.\n\nDELAYED INTENSIFICATION II\\*\\* (SER ONLY): Beginning on day 29, patients (except patients with CNS3 disease) receive 8 daily fractions of cranial radiotherapy. All patients then receive vincristine IV, dexamethasone PO or IV, doxorubicin hydrochloride IV, study drug IV, cyclophosphamide IV, cytarabine IV or SC, thioguanine PO, and methotrexate IT as in delayed intensification I. Patients who were initially diagnosed with CNS3 disease receive cranial radiotherapy on days 1-5 and 8-12. Patients then proceed to maintenance therapy.\n\nMAINTENANCE THERAPY\\*\\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate IT on day 29; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 2 years (for female patients) or up to 3 years (for male patients) from the start of interim maintenance I.\n\nNOTE: \\*\\* As per amendment #4, most patients receive high-dose methotrexate instead of Capizzi methotrexate at most stages of therapy. CNS3 patients and SER patients who have received cranial irradiation receive planned therapy with no modifications.\n\nNOTE: As per amendment #4, the maximum number of intrathecal treatments is limited by RER/SER/CNS3 status and gender.\n\nBlood and cerebrospinal fluid samples are collected periodically for correlative studies, including immunogenicity, pharmacokinetic, and pharmacodynamic studies.\n\nAfter completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, and then every 6-12 months for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be eligible for and enrolled on AALL08B1 or the successor classification study\n* Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization \\[WHO\\] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)\n* White blood cell (WBC) \\>= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids\n* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy\n* Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented\n* Pregnancy tests with a negative result must be obtained in all post-menarchal females\n* Lactating females must agree that they will not breastfeed a child while on this study\n\nExclusion Criteria:\n\n* Patients with Down syndrome are excluded from this study\n* Patients with testicular leukemia at diagnosis are excluded from this study\n* Pregnant female patients are excluded from this study'}, 'identificationModule': {'nctId': 'NCT00671034', 'briefTitle': 'Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL)', 'orgStudyIdInfo': {'id': 'AALL07P4'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00317', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000594340'}, {'id': '08-606'}, {'id': 'COG-AALL07P4'}, {'id': 'AALL07P4', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AALL07P4', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (combination chemotherapy)', 'description': 'Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.', 'interventionNames': ['Drug: Calaspargase Pegol-mknl', 'Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Other: Pharmacological Study', 'Drug: Prednisone', 'Radiation: Radiation Therapy', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (combination chemotherapy)', 'description': 'Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 4 years.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Dexamethasone', 'Drug: Doxorubicin Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Drug: Mercaptopurine', 'Drug: Methotrexate', 'Drug: Pegaspargase', 'Other: Pharmacological Study', 'Drug: Prednisone', 'Radiation: Radiation Therapy', 'Drug: Thioguanine', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': 'Calaspargase Pegol-mknl', 'type': 'DRUG', 'otherNames': ['Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)', 'Asparlas', 'Calaspargase Pegol', 'EZN-2285', 'SC-PEG E. Coli L-Asparaginase', 'Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-Cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IV, IT, PO, or SC', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Daunorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['Cerubidin', 'Cerubidine', 'Cloridrato de Daunorubicina', 'Daunoblastin', 'Daunoblastina', 'Daunoblastine', 'Daunomycin Hydrochloride', 'Daunomycin, hydrochloride', 'Daunorubicin.HCl', 'Daunorubicini Hydrochloridum', 'FI-6339', 'Ondena', 'RP-13057', 'Rubidomycin Hydrochloride', 'Rubilem'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycadron', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decadron DP', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasone Intensol', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Dxevo', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hexadecadrol', 'Hexadrol', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'TaperDex', 'Visumetazone', 'ZoDex'], 'description': 'Given PO or IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'otherNames': ['3H-Purine-6-thiol', '6 MP', '6 Thiohypoxanthine', '6 Thiopurine', '6-Mercaptopurine', '6-Mercaptopurine Monohydrate', '6-MP', '6-Purinethiol', '6-Thiopurine', '6-Thioxopurine', '6H-Purine-6-thione, 1,7-dihydro- (9CI)', '7-Mercapto-1,3,4,6-tetrazaindene', 'Alti-Mercaptopurine', 'Azathiopurine', 'Bw 57-323H', 'Flocofil', 'Ismipur', 'Leukerin', 'Leupurin', 'Mercaleukim', 'Mercaleukin', 'Mercaptina', 'Mercaptopurinum', 'Mercapurin', 'Mern', 'NCI-C04886', 'Puri-Nethol', 'Purimethol', 'Purine, 6-mercapto-', 'Purine-6-thiol (8CI)', 'Purine-6-thiol, monohydrate', 'Purinethiol', 'Purinethol', 'U-4748', 'WR-2785'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Abitrexate', 'Alpha-Methopterin', 'Amethopterin', 'Brimexate', 'CL 14377', 'CL-14377', 'Emtexate', 'Emthexat', 'Emthexate', 'Farmitrexat', 'Fauldexato', 'Folex', 'Folex PFS', 'Lantarel', 'Ledertrexate', 'Lumexon', 'Maxtrex', 'Medsatrexate', 'Metex', 'Methoblastin', 'Methotrexate LPF', 'Methotrexate Methylaminopterin', 'Methotrexatum', 'Metotrexato', 'Metrotex', 'Mexate', 'Mexate-AQ', 'MTX', 'Novatrex', 'Rheumatrex', 'Texate', 'Tremetex', 'Trexeron', 'Trixilem', 'WR-19039'], 'description': 'Given IV, IT, or PO', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'otherNames': ['L-Asparaginase with Polyethylene Glycol', 'Oncaspar', 'Oncaspar-IV', 'PEG-Asparaginase', 'PEG-L-Asparaginase', 'PEG-L-Asparaginase (Enzon - Kyowa Hakko)', 'PEGLA', 'Polyethylene Glycol L-Asparaginase', 'Polyethylene Glycol-L-Asparaginase'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['.delta.1-Cortisone', '1, 2-Dehydrocortisone', 'Adasone', 'Cortancyl', 'Dacortin', 'DeCortin', 'Decortisyl', 'Decorton', 'Delta 1-Cortisone', 'Delta-Dome', 'Deltacortene', 'Deltacortisone', 'Deltadehydrocortisone', 'Deltasone', 'Deltison', 'Deltra', 'Econosone', 'Lisacort', 'Meprosona-F', 'Metacortandracin', 'Meticorten', 'Ofisolona', 'Orasone', 'Panafcort', 'Panasol-S', 'Paracort', 'Perrigo Prednisone', 'PRED', 'Predicor', 'Predicorten', 'Prednicen-M', 'Prednicort', 'Prednidib', 'Prednilonga', 'Predniment', 'Prednisone Intensol', 'Prednisonum', 'Prednitone', 'Promifen', 'Rayos', 'Servisone', 'SK-Prednisone'], 'description': 'Given IV or PO', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Some patients undergo RT', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Thioguanine', 'type': 'DRUG', 'otherNames': ['2-Amino 6MP', '2-Amino-1,7-dihydro-6H-purine-6-thione', '2-Amino-6-mercaptopurine', '2-Amino-6-purinethiol', '2-Aminopurin-6-thiol', '2-Aminopurine-6(1H)-thione', '2-Aminopurine-6-thiol', '2-Aminopurine-6-thiol Hemihydrate', '2-Mercapto-6-aminopurine', '6-Amino-2-mercaptopurine', '6-Mercapto-2-aminopurine', '6-Mercaptoguanine', '6-TG', '6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)', 'BW 5071', 'Lanvis', 'Tabloid', 'Thioguanine Hemihydrate', 'Thioguanine Hydrate', 'Tioguanin', 'Tioguanine', 'Wellcome U3B', 'WR-1141', 'X 27'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (combination chemotherapy)', 'Arm II (combination chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 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'country': 'United States', 'facility': 'Wayne State University/Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota - Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern/Simmons Cancer Center-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 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